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Brexit – will all the medicines get to the patients?

Two years after the UK narrowly voted to exit the EU it remains unclear as to what this may involve. In July 2016, Theresa May stated that “Brexit means Brexit.” But what exactly did that mean?

brexit

It means that the UK is leaving the EU, but it does not explain the UK’s future relationship with the trading bloc. Options abound, such as Hard Brexit, soft Brexit, the hardest-of-hard Brexit, regulatory alignment, and crash-out-without-a-deal Brexit. But with no sign of surety in sight, businesses remain uncertain whether to stick or twist – spend lots of money or wait to see what happens?

The UK Government’s Chequers Plan and White Paper in July were widely praised by the pharma industry, which viewed it as a big step forward in maintaining regulatory alignment with the EU and, notably, a unilateral statement of intent to work with and accept the rules of the European Medicines Agency (EMA). The offer also included a desire to contribute towards the EMA’s costs, and mutual recognition of qualified persons (QP) and qualified persons for pharmacovigilance (QPPV) in each territory, as well as the regulatory experts at the Medicines and Healthcare products Regulatory Agency (MHRA).

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